CN117897118A - Surgical skin preparation device with timing indicator - Google Patents
Surgical skin preparation device with timing indicator Download PDFInfo
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- CN117897118A CN117897118A CN202280056766.4A CN202280056766A CN117897118A CN 117897118 A CN117897118 A CN 117897118A CN 202280056766 A CN202280056766 A CN 202280056766A CN 117897118 A CN117897118 A CN 117897118A
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- 239000000203 mixture Substances 0.000 claims abstract description 110
- 239000000463 material Substances 0.000 claims abstract description 52
- 230000002421 anti-septic effect Effects 0.000 claims abstract description 51
- 230000000844 anti-bacterial effect Effects 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 15
- 230000001954 sterilising effect Effects 0.000 claims description 15
- 238000004891 communication Methods 0.000 claims description 14
- 239000012530 fluid Substances 0.000 claims description 14
- 230000002070 germicidal effect Effects 0.000 claims description 7
- 230000000249 desinfective effect Effects 0.000 claims description 6
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- 230000000845 anti-microbial effect Effects 0.000 description 6
- 238000011477 surgical intervention Methods 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 5
- KUXUALPOSMRJSW-IFWQJVLJSA-N 2-[6-[[amino-[[amino-(4-chloroanilino)methylidene]amino]methylidene]amino]hexyl]-1-[amino-(4-chloroanilino)methylidene]guanidine;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 KUXUALPOSMRJSW-IFWQJVLJSA-N 0.000 description 3
- 241000588724 Escherichia coli Species 0.000 description 3
- 241000588747 Klebsiella pneumoniae Species 0.000 description 3
- YZBQHRLRFGPBSL-RXMQYKEDSA-N carbapenem Chemical compound C1C=CN2C(=O)C[C@H]21 YZBQHRLRFGPBSL-RXMQYKEDSA-N 0.000 description 3
- YZIYKJHYYHPJIB-UUPCJSQJSA-N chlorhexidine gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 YZIYKJHYYHPJIB-UUPCJSQJSA-N 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 244000005700 microbiome Species 0.000 description 3
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 3
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- OSDLLIBGSJNGJE-UHFFFAOYSA-N 4-chloro-3,5-dimethylphenol Chemical compound CC1=CC(O)=CC(C)=C1Cl OSDLLIBGSJNGJE-UHFFFAOYSA-N 0.000 description 2
- 229930186147 Cephalosporin Natural products 0.000 description 2
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 2
- 241000191967 Staphylococcus aureus Species 0.000 description 2
- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical compound OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 229940124587 cephalosporin Drugs 0.000 description 2
- 150000001780 cephalosporins Chemical class 0.000 description 2
- 229960003333 chlorhexidine gluconate Drugs 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
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- 229920003023 plastic Polymers 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 229960003500 triclosan Drugs 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- GDXCHXZXSDPUCJ-UHFFFAOYSA-N 3-chloro-4-methyl-4,5-dihydro-1,2-thiazole Chemical compound CC1CSN=C1Cl GDXCHXZXSDPUCJ-UHFFFAOYSA-N 0.000 description 1
- YMTZCQOAGFRQHV-UHFFFAOYSA-N 3-methyl-4,5-dihydro-1,2-thiazole Chemical compound CC1=NSCC1 YMTZCQOAGFRQHV-UHFFFAOYSA-N 0.000 description 1
- 241000589291 Acinetobacter Species 0.000 description 1
- 241000588626 Acinetobacter baumannii Species 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000222120 Candida <Saccharomycetales> Species 0.000 description 1
- 241000193163 Clostridioides difficile Species 0.000 description 1
- IMXSCCDUAFEIOE-UHFFFAOYSA-N D-Octopin Natural products OC(=O)C(C)NC(C(O)=O)CCCN=C(N)N IMXSCCDUAFEIOE-UHFFFAOYSA-N 0.000 description 1
- IMXSCCDUAFEIOE-RITPCOANSA-N D-octopine Chemical compound [O-]C(=O)[C@@H](C)[NH2+][C@H](C([O-])=O)CCCNC(N)=[NH2+] IMXSCCDUAFEIOE-RITPCOANSA-N 0.000 description 1
- 206010013786 Dry skin Diseases 0.000 description 1
- 241000588921 Enterobacteriaceae Species 0.000 description 1
- 241000194031 Enterococcus faecium Species 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
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- 241001465754 Metazoa Species 0.000 description 1
- RJQXTJLFIWVMTO-TYNCELHUSA-N Methicillin Chemical compound COC1=CC=CC(OC)=C1C(=O)N[C@@H]1C(=O)N2[C@@H](C(O)=O)C(C)(C)S[C@@H]21 RJQXTJLFIWVMTO-TYNCELHUSA-N 0.000 description 1
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- 241000295644 Staphylococcaceae Species 0.000 description 1
- 108010059993 Vancomycin Proteins 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 1
- 229960001950 benzethonium chloride Drugs 0.000 description 1
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 1
- 150000004287 bisbiguanides Chemical class 0.000 description 1
- 229960002152 chlorhexidine acetate Drugs 0.000 description 1
- 229960005443 chloroxylenol Drugs 0.000 description 1
- SOROIESOUPGGFO-UHFFFAOYSA-N diazolidinylurea Chemical compound OCNC(=O)N(CO)C1N(CO)C(=O)N(CO)C1=O SOROIESOUPGGFO-UHFFFAOYSA-N 0.000 description 1
- 229960001083 diazolidinylurea Drugs 0.000 description 1
- 230000037336 dry skin Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- SLKWROUNLHVIIQ-UHFFFAOYSA-N hexachlorocyclohexa-2,5-dien-1-one Chemical compound ClC1=C(Cl)C(Cl)(Cl)C(Cl)=C(Cl)C1=O SLKWROUNLHVIIQ-UHFFFAOYSA-N 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000000977 initiatory effect Effects 0.000 description 1
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 description 1
- 238000002357 laparoscopic surgery Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229910001092 metal group alloy Inorganic materials 0.000 description 1
- 229960003085 meticillin Drugs 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 230000000877 morphologic effect Effects 0.000 description 1
- 239000005445 natural material Substances 0.000 description 1
- 238000013188 needle biopsy Methods 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 239000008104 plant cellulose Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- MCSINKKTEDDPNK-UHFFFAOYSA-N propyl propionate Chemical compound CCCOC(=O)CC MCSINKKTEDDPNK-UHFFFAOYSA-N 0.000 description 1
- 125000001453 quaternary ammonium group Chemical group 0.000 description 1
- 239000002964 rayon Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000011012 sanitization Methods 0.000 description 1
- 238000005201 scrubbing Methods 0.000 description 1
- MYPYJXKWCTUITO-LYRMYLQWSA-N vancomycin Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-N 0.000 description 1
- 229960003165 vancomycin Drugs 0.000 description 1
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
- A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
- A61M35/006—Portable hand-held applicators having means for dispensing or spreading integral media using sponges, foams, absorbent pads or swabs as spreading means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/80—Implements for cleaning or washing the skin of surgeons or patients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/04—Skin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Surgical Instruments (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
A surgical skin preparation device for applying a antiseptic composition to skin of a patient is provided, the surgical skin preparation device comprising an applicator configured to absorb the antiseptic composition, the applicator having a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to skin of the patient, and an indicator comprising a first layer of a first material configured to wick the antiseptic composition, the first material being opaque in a first state, transparent or translucent in a second state, the second layer having at least one indicium that is visible to a user when the first layer is in a second state.
Description
Cross Reference to Related Applications
The present application claims priority from U.S. provisional application No. 63/234,097 entitled "Surgical Skin Preparation Device with Timed Indicator (surgical skin preparation device with timing indicator)" filed on 8/17 of 2021, the entire disclosure of which is incorporated herein by reference in its entirety.
Background
Technical Field
The present invention relates to an indication device for surgical preparation. More particularly, the present invention relates to the use of an indicator for use with a surgical skin preparation device that allows a user to know that a predetermined, sufficient scrubbing duration has been applied to a surgical site.
Background
Proper cleaning and sterilization of the surgical site is critical to reduce the likelihood of adverse events (including infection) during and after intervention. However, for a number of reasons (from the pressure at which the patient is quickly prepared for surgery to the inherent disturbance of the environment), many clinicians and other surgical staff do not employ appropriate cleaning and disinfection techniques, such as the following guidelines are suggested: the dry skin area was cleaned for 30 seconds and then dried for 30 seconds.
Accordingly, there is a need in the art for improved devices and methods for properly preparing a site for surgical intervention.
Disclosure of Invention
According to an embodiment of the present invention, a surgical skin preparation device for applying a antiseptic composition to the skin of a patient includes an applicator configured to absorb the antiseptic composition. The applicator includes a top surface and a bottom surface configured to apply the antiseptic composition to the skin of a patient. The surgical preparation device further includes an indicator comprising a first layer having a first material configured to wick the bactericidal composition, wherein the first material is opaque in a first state and transparent or translucent in a second state, and a second layer comprising a non-wettable material, the second layer comprising at least one indicia that is visible to a user when the first layer is in the second state.
The indicator may be disposed on the top surface of the applicator, and the second layer of the indicator may be disposed between the top surface of the applicator and the first layer of the indicator. Alternatively, the device may comprise a handle having a proximal end and a distal end, wherein the applicator is disposed at the distal end of the handle. The indicator may be disposed at the distal end of the handle, the second layer of the indicator being disposed between the top surface of the applicator and the first layer of the indicator. The handle may be configured to store the bactericidal composition. Optionally, the handle defines a path that fluidly connects the antiseptic composition and the applicator. The bactericidal composition can be stored in a container that is frangible or can be pierced.
In other configurations, the handle may include one or more actuatable elements configured to break or pierce the container. In certain configurations, the first layer is in the first state when the bactericidal composition has not been wicked along the first layer, and the first layer is in the second state when the bactericidal composition is wicked along the first layer by more than about 50%, alternatively more than about 75%, alternatively more than about 90%. Optionally, the first material is configured such that the sterilizing composition is wicked along most or all of the length of the first layer about 30 seconds after initial exposure to the sterilizing composition.
The first layer may be configured to gradually change from the first state to the second state as the biocidal composition is wicked from the first end of the first layer to the second end of the first layer. The first material may be configured to wick more than about 50%, alternatively more than about 75%, alternatively more than about 90% through the first layer about 30 seconds after initial exposure to the antiseptic composition. In certain configurations, the applicator is circular in shape. In other configurations, the applicator is quadrilateral in shape. Optionally, the indicia includes one or more of a color and a symbol.
According to another embodiment of the invention, a method of disinfecting skin includes applying a disinfecting composition to skin of a patient with a device until the indicia is at least partially visible to a user. The device includes an applicator configured to absorb the bactericidal composition. The applicator includes a top surface and a bottom surface configured to apply the antiseptic composition to the skin of a patient. The surgical preparation device further includes an indicator comprising a first layer having a first material configured to wick the bactericidal composition, wherein the first material is opaque in a first state and transparent or translucent in a second state, and a second layer comprising at least one indicia that is visible to a user when the first layer is in the second state.
The method may further comprise applying the antiseptic composition to the skin of the patient for at least 30 seconds before the indicia is at least partially visible to the user.
According to another embodiment of the present invention, a method of sanitizing skin includes providing a device having a handle with a proximal end, a distal end, a sidewall between the proximal end and the distal end, and one or more actuatable elements disposed along the sidewall, the sidewall defining an at least partially hollow interior. The device also includes a frangible or pierceable container holding the sterilizing composition received within the at least partially hollow interior, the container configured to be broken or pierced by the one or more actuatable elements. The device also includes an applicator disposed at the distal end of the handle and in fluid communication with the at least partially hollow interior, the applicator configured to absorb the antiseptic composition after breaking or puncturing the container, the applicator including a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of a patient. The device further includes an indicator having a first layer comprising a first material configured to wick the germicidal composition, wherein the first material is opaque when dry and transparent or translucent when wet, and a second layer comprising a non-wettable material, the second layer comprising at least one indicia that is visible to a user when the first layer is wet. The method further comprises the steps of: actuating the one or more actuatable elements to break or pierce the container; and applying the antiseptic composition to the skin of the patient until the indicia is at least partially visible.
According to yet another embodiment of the present invention, a device includes a handle having a proximal end, a distal end, a sidewall between the proximal end and the distal end, and one or more actuatable elements disposed along the sidewall, wherein the sidewall defines an at least partially hollow interior. The device also includes a frangible or pierceable container holding the sterilizing composition received within the at least partially hollow interior, the container configured to be broken or pierced by the one or more actuatable elements. The device also includes a circular applicator disposed at the distal end of the handle and in fluid communication with the at least partially hollow interior, the applicator configured to absorb the antiseptic composition after breaking or puncturing the container, the applicator including a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of a patient. The device also includes an indicator at least partially disposed on a top surface of the applicator. The indicator includes a first layer in fluid communication with the applicator and comprising a first material configured to wick the antiseptic composition, wherein the first material is opaque when dry and transparent or translucent when wet. The indicator also includes a second layer disposed between the first layer and the applicator and comprising a non-wettable material, the second layer including at least one indicia that is visible to a user when the first layer is wet.
According to yet another embodiment, a device includes a handle having a proximal end, a distal end, a sidewall between the proximal end and the distal end, and one or more actuatable elements disposed along the sidewall, wherein the sidewall defines an at least partially hollow interior. The device also includes a frangible or pierceable container holding the sterilizing composition received within the at least partially hollow interior, the container configured to be broken or pierced by the one or more actuatable elements. The device also includes a quadrilateral applicator disposed at the distal end of the handle and in fluid communication with the at least partially hollow interior, the applicator configured to absorb the antiseptic composition after breaking or puncturing the container, the applicator including a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of a patient. The device also includes an indicator disposed at least partially on the top surface of the applicator and comprising a first layer in fluid communication with the applicator and comprising a first material configured to wick the antiseptic composition, wherein the first material is opaque when dry and transparent or translucent when wet. The indicator also includes a second layer disposed between the first layer and the applicator and comprising a non-wettable material, the second layer including at least one indicia that is visible to a user when the first layer is wet.
Drawings
FIG. 1A is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 1B is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 2A is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 2B is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 3 is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 4 is an enlarged perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 5 is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 6 is a perspective view of a device including an indicator according to a non-limiting embodiment or aspect described herein;
FIG. 7A is a schematic diagram of an indicator according to a non-limiting embodiment or aspect described herein; and
fig. 7B is a schematic diagram of an indicator according to a non-limiting embodiment or aspect described herein.
Detailed Description
The following description is presented to enable one of ordinary skill in the art to make and use the described aspects of the invention as contemplated for its practice. Various modifications, equivalents, changes, and alternatives will, however, be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.
Unless explicitly stated otherwise, the use of numerical values within the various ranges specified in this application is stated in approximation as if the minimum and maximum values within the stated ranges were preceded by the word "about". In this way, slight variations above and below the illustrated ranges can be used to achieve substantially the same results as values within the ranges. Furthermore, unless otherwise indicated, the disclosure of these ranges is intended as a continuous range including each value between the minimum and maximum values. For the definitions provided herein, these definitions refer to morphological, cognate, and grammatical variations of such words or phrases.
The drawings accompanying this application are representative in nature and should not be construed as implying any particular ratio or orientation unless otherwise indicated. Hereinafter, for the purposes of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and derivatives thereof shall relate to the invention as oriented in the drawings. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Thus, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
Provided herein is a device for applying a bactericidal composition to the skin of a patient, for example for preparing an area of the patient's skin for surgical intervention. As used herein, the term "patient" is any animal, including humans, and "human patient" is any human. As used herein, the term "bactericidal composition" is any composition that prevents or inhibits the growth of one or more microorganisms.
In non-limiting embodiments or aspects, the bactericidal composition includes one or more alcohols, such as ethanol, propanol, isopropanol, n-propanol, and/or mixtures thereof. In non-limiting embodiments or aspects, the bactericidal composition includes one or more non-alcohol based compounds such as iodine, parachlorometaxylenol, bis-biguanides (e.g., chlorhexidine gluconate (chlorhexidine gluconate, CHG)), chlorhexidine acetate, or quaternary ammonium based compounds (e.g., benzethonium chloride, benzalkonium chloride, chloroxylenol, triclosan, hexachlorophenol, octopine, diazolidinyl urea, methyl chloroisothiazoline, methyl isothiazoline, triclosan, and/or mixtures thereof). In non-limiting embodiments or aspects, the antimicrobial composition includes a mixture of any of the above, including a mixture of an alcohol and a non-alcohol based compound. In non-limiting embodiments or aspects, the antiseptic composition includes CHG and an alcohol (e.g., isopropyl alcohol). In a non-limiting embodiment or aspect, the bactericidal composition includes about 2% (w/v) CHG and about 70% (v/v) isopropyl alcohol.
In non-limiting embodiments or aspects, the bactericidal composition is effective against one or more microorganisms (e.g., bacteria, viruses, and/or fungi). In non-limiting embodiments or aspects, the microorganism is one or more of the following: coagulase-negative staphylococci, staphylococcus aureus (including methicillin-resistant Staphylococcus aureus), enterococci (including vancomycin-resistant enterococci such as enterococcus faecium), candida, escherichia coli (including ultra-broad-spectrum cephalosporin-resistant escherichia coli and carbapenem-resistant escherichia coli), clostridium difficile, pseudomonas aeruginosa (including carbapenem-resistant pseudomonas aeruginosa), klebsiella pneumoniae (including ultra-broad-spectrum cephalosporin-resistant klebsiella pneumoniae and carbapenem-resistant klebsiella pneumoniae), enterobacteriaceae, acinetobacter (including acinetobacter baumannii), and klebsiella oxytoca.
As used herein, the term "surgical intervention" refers to any percutaneous treatment (e.g., catheterization, angioplasty, needle biopsy, etc.), open surgery, laparoscopic surgery, and/or minimally invasive surgery involving puncturing the skin or creating one or more incisions of different sizes on the patient's skin.
Turning to fig. 1-6, these figures illustrate exemplary non-limiting embodiments or aspects of a device 100 for applying a antiseptic composition to the skin of a patient. The device 100 includes an applicator 110, such as a sponge or other porous absorbent material, configured to hold the antiseptic composition and allow a user to apply the antiseptic composition to the patient's skin at the surgical intervention site and optionally at one or more areas near the surgical intervention site. Applicator 110 may be a natural sponge, a synthetic sponge (synthetic sponge including, for example, but not limited to, polyurethane, polyester, and/or plant cellulose) or other suitable material (so long as the material is capable of absorbing and/or dispensing a bactericidal composition). Applicator 110 may have a top surface 112 and a bottom surface 114. Either surface may be used to apply the antiseptic composition to the skin of a patient; however, for simplicity, the device 100 will be described herein with reference to the bottom surface 114 serving as a surface configured to contact the skin of a patient.
In a non-limiting embodiment or aspect, the device 100 includes a handle 130 to allow a user to apply the antiseptic composition to the skin of a patient while maintaining an antiseptic technique (e.g., by not directly contacting the applicator). In non-limiting embodiments or aspects, the handle 130 can be configured to have a distal end 132 and a proximal end 134, with the applicator 110 disposed at the distal end 132, as shown, for example, in fig. 1-4 and 6, and a sidewall 136 between the distal and proximal ends. In a non-limiting embodiment or aspect, the handle 130 can be arranged as shown in fig. 5, wherein the handle sidewall 136 is in contact with the applicator 110. The handle 130 may be formed of any useful material (e.g., metal alloy, and/or plastic).
In a non-limiting embodiment or aspect, the handle 130 is at least partially hollow and is configured to retain the sterilizing composition therein and to allow fluid communication between the sterilizing composition retained therein and the applicator 110. In this manner, the device 100 may be provided as a sterilization package, wherein the device 100 and the sterilization composition are pre-packaged as a single unit. In a non-limiting embodiment or aspect, the antiseptic composition is stored within a container that is held within the handle 130 such that the applicator 110 is not in contact with the antiseptic composition during storage/prior to use. In non-limiting embodiments or aspects, the container is a frangible or pierceable container formed of glass, plastic, or other suitable material. This arrangement allows the user to control the initiation of contact between the antimicrobial composition and the applicator 110. In non-limiting embodiments or aspects, such as shown in fig. 6, the side wall 136 of the handle 130 may be flexible and/or resilient such that a user may apply radially inward pressure to the side wall 136 to break the container or cause the container to be pierced.
In non-limiting embodiments or aspects, the handle 130 includes one or more actuatable elements 140 that when actuated can cause a container within the handle 130 to be broken or pierced, thereby allowing the antiseptic composition to contact the applicator 110. The one or more actuatable elements 140 may take any useful form, such as, but not limited to, the forms shown in fig. 1-5, so long as the actuatable elements are capable of being actuated by a user to cause release of the germicidal composition. The one or more actuatable elements 140 may include ergonomic features and/or features that improve the grip of the user and/or reduce slippage, such as texture.
With continued reference to the figures, the device 100 includes an indicator 120 configured to alert a user that the antiseptic composition has been applied to the skin for a sufficient amount of time. As shown in fig. 7A and 7B, the indicator 120 includes a first layer 122 and a second layer 124. From the perspective of the user, the first layer 122 is disposed on a surface of the second layer 124. For example, in the non-limiting embodiment or aspect shown in fig. 1-4, a second layer (not visible) is disposed between the first layer of the indicator 120 and the applicator 110. In a non-limiting embodiment or aspect, the indicator 120 is arranged such that the first layer 122 is larger than the second layer 124 (e.g., the first layer has a larger circumference) such that the first layer 122 can be in fluid communication with the applicator 110. By employing this configuration, the first layer 122 can be in contact with the antimicrobial composition in the applicator 110. In a non-limiting embodiment or aspect, the indicator 120 is disposed at the distal end of the handle 130 (or at the edge of the handle 130 in the embodiment shown in fig. 5, for example). Those skilled in the art will appreciate that the indicator 120 may be arranged in any useful manner so long as the first layer 122 may be in fluid communication with the disinfecting composition.
For example, as shown in fig. 7A and 7B, the first layer 122 may be formed of: the material may transport the antiseptic composition from a first end of the layer (e.g., the first end is in fluid communication with the antiseptic composition, e.g., by contact with the applicator 100) to an opposite second end, e.g., by capillary action (e.g., wicking). In a non-limiting embodiment or aspect, the first layer is formed of a wettable material. As used herein, the term "wettable" means that the surface of the material has a contact angle with water of 75 ° or less, alternatively 60 ° or less, and is capable of transporting a liquid such as a bactericidal composition by capillary action.
The first layer 122 may be formed of the following materials: the material is opaque or substantially opaque when in a first (e.g., dry) state and translucent or transparent (or substantially translucent or transparent) when in a second (e.g., wet) state. Because, in a non-limiting embodiment, the first layer is formed of a material capable of wicking the germicidal composition, as the material becomes wet and the germicidal composition is wicked toward the distal end of the indicator, more and more portions of the first layer become increasingly wet (and thus transparent or translucent), allowing the second layer 124 to be increasingly exposed to the user. In non-limiting embodiments or aspects, the first layer 122 may be formed from a polymeric material such as polyester, polypropylene, nylon, and/or rayon, and/or a natural material such as paper-based material, and/or wool such as Merino wool (Merino wool).
The second layer 124 may be formed of any non-wettable material. As used herein, the term "non-wettable" refers to a material having a surface with a contact angle of 90 ° or greater with water. The second layer 124 includes indicia 128, and due to the variable opaque and translucent and/or transparent nature of the first layer 122, the indicia 128 is only visible to a user when the first layer 122 is partially or completely transparent or translucent (e.g., when the antimicrobial composition is wicked along a portion or the entire length of the layer). In a non-limiting embodiment or aspect, the indicia 128 is a colored portion that is present on at least a portion of the second layer 124, such as by printing on the layer. In a non-limiting embodiment or aspect, the second layer 124 includes a color along at least a portion of the layer, optionally along substantially all of the layer, optionally along the entire layer, such that more and more of the color is visible as the biocidal composition is further wicked along the first layer. In a non-limiting embodiment or aspect, the indicia 128 is a symbol present on at least a portion of the second layer 124. In a non-limiting embodiment or aspect, the indicia 128 is disposed at the end of the first layer 124, underneath the portion of the first layer 122 (due to wicking) that ultimately contacts the antimicrobial composition.
Referring to fig. 7B, such an end is disposed at the top of the image. In this way, the indicia 128 is only visible when the antiseptic composition is wicked along substantially the entire, optionally the entire length of the first layer, thereby indicating that the antiseptic composition has been applied to the patient's skin for a sufficient period of time to provide adequate disinfection. In non-limiting embodiments or aspects, the first layer 122 can be formed from a non-wettable polymer or paper-based material (including materials coated to provide non-wettable properties).
Those skilled in the art will recognize that suitable materials may be selected to provide a predetermined elapsed time when partial and/or semi-transparent, and/or complete transparent and/or semi-transparent occurs, which corresponds to a suitable time for applying the antimicrobial composition to the site of the surgical intervention. In a non-limiting embodiment or aspect, the material is configured such that partial transparency and/or translucency, and/or complete transparency and/or translucency is achieved about 30 seconds after initial exposure of the indicator 120 to the germicidal composition.
In a non-limiting embodiment or aspect, the indicator 120 described herein may be used with an application device such as that commercially available from Becton, dickinson and Company (Becton, dickinson corporation) under the trade name CHLORAPREP, and/or that described in, for example, but not limited to, U.S. patent nos. 6,916,133 and 9,750,922, the contents of which are incorporated herein by reference in their entirety.
Also provided herein are methods of disinfecting skin using the devices described above. Such methods include the step of applying the antiseptic composition to the skin of a patient using the devices described herein until the indicia 128 is at least partially visible to the user. In a non-limiting embodiment or aspect, the antiseptic composition is applied to the skin for about 30 seconds before the indicia 128 is visible to the user. In non-limiting embodiments or aspects, the method further comprises the step of actuating one or more actuatable elements 140 or squeezing the side walls 136 to release the sterilizing composition from the container received within the handle 130 prior to application of the sterilizing composition.
Although the invention has been described in accordance with the foregoing detailed description, those of ordinary skill in the art will understand that changes can be made without departing from the spirit of the invention. The above description should not be taken as limiting, and the scope of the invention is defined by the appended claims.
Claims (20)
1. A surgical skin preparation device for applying a bactericidal composition to the skin of a patient, the surgical skin preparation device comprising:
an applicator configured to absorb the antiseptic composition, the applicator comprising a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of the patient; and
an indicator, the indicator comprising:
a first layer comprising a first material configured to wick the germicidal composition, wherein the first material is opaque in a first state and transparent or translucent in a second state; and
a second layer comprising a non-wettable material, the second layer comprising at least one indicia, the at least one indicia being visible to a user when the first layer is in the second state.
2. The device of claim 1, wherein the indicator is disposed on the top surface of the applicator and the second layer of the indicator is disposed between the top surface of the applicator and the first layer of the indicator.
3. The device of claim 1, further comprising a handle having a proximal end and a distal end, and wherein the applicator is disposed at the distal end of the handle.
4. A device according to claim 3, wherein the indicator is arranged at the distal end of the handle and the second layer of the indicator is arranged between the top surface of the applicator and the first layer of the indicator.
5. The device of claim 3 or 4, wherein the handle is configured to store the bactericidal composition.
6. The device of claim 5, wherein the handle defines a path that fluidly connects the antiseptic composition and the applicator.
7. A device according to claim 5 or 6, wherein the bactericidal composition is stored in a frangible or pierceable container.
8. The device of claim 7, wherein the handle further comprises one or more actuatable elements configured to break or pierce the container.
9. The device of any one of claims 1 to 8, wherein the first layer is in the first state when the bactericidal composition has not been wicked along the first layer, and the first layer is in the second state when the bactericidal composition has been wicked along the first layer more than about 50%, optionally more than about 75%, optionally more than about 90%.
10. The device of claim 9, wherein the first material is configured such that the bactericidal composition is wicked along most or all of the length of the first layer about 30 seconds after initial exposure to the bactericidal composition.
11. The device of any one of claims 1-8, wherein the first layer is configured to gradually change from the first state to the second state as the bactericidal composition is wicked from a first end of the first layer to a second end of the first layer.
12. The device of claim 8, wherein the first material is configured such that the bactericidal composition is wicked through more than about 50%, alternatively more than about 75%, alternatively more than about 90% of the first layer about 30 seconds after initial exposure to the bactericidal composition.
13. The device of any one of claims 1 to 12, wherein the applicator is circular in shape.
14. The device of any one of claims 1 to 12, wherein the applicator is quadrilateral in shape.
15. The apparatus of any one of claims 1 to 14, wherein the indicia comprises one or more of a color and a symbol.
16. A method of disinfecting skin, the method comprising:
applying the antiseptic composition to the skin of a patient using the device of any of claims 1-15 until the marking is at least partially visible to the user.
17. The method of claim 16, wherein the antiseptic composition is applied to the patient's skin for at least 30 seconds before the indicia is at least partially visible to the user.
18. A method of disinfecting skin, the method comprising:
there is provided an apparatus comprising:
a handle comprising a proximal end, a distal end, a sidewall between the proximal end and the distal end, the sidewall defining an at least partially hollow interior, and one or more actuatable elements disposed along the sidewall;
a frangible or pierceable container holding a sterilizing composition received within the at least partially hollow interior, the container configured to be broken or pierced by the one or more actuatable elements;
an applicator disposed at the distal end of the handle and in fluid communication with the at least partially hollow interior, the applicator configured to absorb the antiseptic composition after breaking or puncturing the container, the applicator comprising a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of a patient; and
an indicator, the indicator comprising:
a first layer comprising a first material configured to wick the germicidal composition, wherein the first material is opaque when dry and transparent or translucent when wet; and
a second layer comprising a non-wettable material, the second layer comprising at least one indicia that is visible to a user when the first layer is wet;
actuating the one or more actuatable elements to break or pierce the container; and
the antiseptic composition is applied to the skin of the patient until the indicia is at least partially visible.
19. An apparatus, the apparatus comprising:
a handle comprising a proximal end, a distal end, a sidewall between the proximal end and the distal end, the sidewall defining an at least partially hollow interior, and one or more actuatable elements disposed along the sidewall;
a frangible or pierceable container holding a sterilizing composition received within the at least partially hollow interior, the container configured to be broken or pierced by the one or more actuatable elements;
a circular applicator disposed at the distal end of the handle and in fluid communication with the at least partially hollow interior, the applicator configured to absorb the antiseptic composition after breaking or puncturing the container, the applicator comprising a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of a patient; and
an indicator disposed at least partially on the top surface of the applicator and comprising:
a first layer in fluid communication with the applicator and comprising a first material configured to wick the antiseptic composition, wherein the first material is opaque when dry and transparent or translucent when wet; and
a second layer disposed between the first layer and the applicator and comprising a non-wettable material, the second layer comprising at least one indicia that is visible to a user when the first layer is wet.
20. An apparatus, the apparatus comprising:
a handle comprising a proximal end, a distal end, a sidewall between the proximal end and the distal end, the sidewall defining an at least partially hollow interior, and one or more actuatable elements disposed along the sidewall;
a frangible or pierceable container holding a sterilizing composition received within the at least partially hollow interior, the container configured to be broken or pierced by the one or more actuatable elements;
a quadrilateral applicator disposed at the distal end of the handle and in fluid communication with the at least partially hollow interior, the applicator configured to absorb the antiseptic composition after breaking or puncturing the container, the applicator comprising a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of a patient; and
an indicator disposed at least partially on the top surface of the applicator and comprising:
a first layer in fluid communication with the applicator and comprising a first material configured to wick the antiseptic composition, wherein the first material is opaque when dry and transparent or translucent when wet; and
a second layer disposed between the first layer and the applicator and comprising a non-wettable material, the second layer comprising at least one indicia that is visible to a user when the first layer is wet.
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